The Impact of Multimodality Treatment on Physical Functions and Quality of Life in Patients With Head and Neck Cancer

NCT05036902 | Completed

• 1 other identifier: 2016/2578
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

Oral cancer (including the lip) alone, with 300.373 cases worldwide in 2012, is the predominant head and neck squamous cell carcinoma. With an incidence of 6.5 cases per 100.000, south - east asia has the highest incidence worldwide. Many of these cases do present at a locally advanced stage, which often requires combined modality treatment that includes extensive surgery to the primary site and neck and flap reconstruction. This is often followed by either adjuvant radiation or chemo-radiotherapy. This treatment can come with a significant morbidity affecting the self-care ability of the patients as well as impact the quality of life(QOL) (3,4).At the SingHealth Duke - NUS Head and Neck Centre 340 complex cases of head and neck cancer (HNC) involving flap reconstructions and extensive resections have been operated in 2014 alone. Almost all of these patients need further adjuvant treatment (radiotherapy and/or chemotherapy). Side-effects following such treatments, Significant number of patients underwent subsequent adjuvant treatment. The adjuvant treatment and surgery may render these patients weakness of the shoulder and neck muscles, numbness and reduced sensation around the neck and shoulder region and a general impact on the patient's fitness. While survival remains the most important outcome in oncologic treatment, recovery of treatment related morbidity and return to pre-treatment QOL for patients after cancer treatment is equally important. The aims of this study is to evaluate the impact of surgical and adjuvant treatment on physical functions and QOL of the patients. By measuring the impact of extensive treatments for head and neck malignancies on the fitness and QOL of these patients, the team aims to identify the risk factors that necessitate a more aggressive rehabilitation. This is to date the first prospective study investigating the impact of multimodality treatment on fitness and QOL in HNC patients in a structured and predefined manner. Ultrasound (US) elastography will be used to assess muscle and soft tissue stiffness and elasticity and correlate these with functional outcome measurements. Elastography has been previously described as a useful tool to assess stiffness of the neck soft tissues and muscles, however no study thus far has correlated these findings with functional measurements. Hence this trial aims to establish the following:

1. 1.Due to the limited available data: to quantify and qualify the impact of surgery as well as adjuvant treatment on the fitness, physical function of the neck and shoulder \& QOL of HNC patients
2. 2.To establish a workflow and assessment protocol for a subsequent larger prospective clinical trial
3. 3.To identify performance markers in these patients, that allow a more targeted rehabilitation process
4. 4.Many patients post head and neck treatment are economically compromised since they are unable to return to mainstream work and there exists a significant unemployment rate. The understanding we gain through objective analysis apart from targeted treatment for every individual patient, in the future this study hopes to address and improve the economic impact to the individual and probably reduce the health care burden.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (18)

• Change from baseline Shoulder Range of Motion at 6 weeks

  Active and passive shoulder movements include abduction, adduction, and flexion, and extension, internal and external rotation.

  1-2 weeks pre surgery, 3-6 weeks post surgery

• Change from post op 6weeks Shoulder Range of Motion at 6 months

  Active and passive shoulder movements include abduction, adduction, and flexion, and extension, internal and external rotation.

  3-6 weeks post surgery, 6 months post surgery

• Change from baseline Bilateral Strength at 6 weeks

  Strength test of the upper and lower limbs will also be performed using an isometric hand-held dynamometer.

  1-2 weeks pre surgery, 3-6 weeks post surgery

• Change from post op 6 weeks Bilateral Strength at 6 months

  Strength test of the upper and lower limbs will also be performed using an isometric hand-held dynamometer.

  3-6 weeks post surgery, 6 months post surgery

• Change from baseline Head Range of Motion at 6 weeks

  Head range of movement will be assessed pre and post treatment using a light source together with the motion capture system. Restrictions in flexion, lateral flexion and rotation will be quantified along with angular velocity and acceleration.

  1-2 weeks pre surgery, 3-6 weeks post surgery

• Change from post op 6 weeks Head Range of Motion at 6 months

  Head range of movement will be assessed pre and post treatment using a light source together with the motion capture system. Restrictions in flexion, lateral flexion and rotation will be quantified along with angular velocity and acceleration.

  3-6 weeks post surgery, 6 months post surgery

• Change from baseline Shoulder Pain and Disability Index questionnaire at 6 weeks

  to evaluate shoulder pain and impairment. To answer the questions, patients place a mark on a 10cm visual analogue scale for each question. The means of the two subscales are averaged to produce a total score ranging from 0 (best) to 100 (worst).

  1-2 weeks pre surgery, 3-6 weeks post surgery

• Change from post op 6 weeks Shoulder Pain and Disability Index questionnaire at 6 months

  to evaluate shoulder pain and impairment. To answer the questions, patients place a mark on a 10cm visual analogue scale for each question. The means of the two subscales are averaged to produce a total score ranging from 0 (best) to 100 (worst).

  3-6 weeks post surgery, 6 months post surgery

• Change from baseline EMG Muscle Activation Patterns at 6 weeks

  Sternocleidomastoid muscle, Serratus anterior, Rhomboid major muscle, Upper trapezius muscle, Middle trapezius muscle

  1-2 weeks pre surgery, 3-6 weeks post surgery

• Change from post op 6 weeks EMG Muscle Activation Patterns at 6 months

  Sternocleidomastoid muscle, Serratus anterior, Rhomboid major muscle, Upper trapezius muscle, Middle trapezius muscle

  3-6 weeks post surgery, 6 months post surgery

• Change from baseline thickness of the SCM (or trapezius) muscle at 6 weeks

  1-2 weeks pre surgery, 3-6 weeks post surgery

• Change from post op 6 weeks thickness of the SCM (or trapezius) muscle at 6 months

  3-6 weeks post surgery, 6 months post surgery

• Change from baseline Maximum Rate of Oxygen consumption measured at 6 weeks

  1-2 weeks pre surgery, 3-6 weeks post surgery

• Change from post op 6 weeks Maximum Rate of Oxygen consumption measured at 6 months

  3-6 weeks post surgery, 6 months post surgery

• Change from baseline EORTC QLQ C30 (European Organisation for Research and Treatment of Cancer quality of life questionnaire) at 6 weeks

  Quality of Life measurement. The EORTC quality of life questionnaire (QLQ) is an integrated system for assessing the health related quality of life (QoL) of cancer patients participating in international clinical trials. The core questionnaire, the QLQ-C30, is the product of more than a decade of collaborative research. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems

  1-2 weeks pre surgery, 3-6 weeks post surgery

• Change from post op 6 weeks EORTC QLQ C30 ((European Organisation for Research and Treatment of Cancer quality of life questionnaire) at 6 months

  Quality of Life measurement. The EORTC quality of life questionnaire (QLQ) is an integrated system for assessing the health related quality of life (QoL) of cancer patients participating in international clinical trials. The core questionnaire, the QLQ-C30, is the product of more than a decade of collaborative research. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems

  3-6 weeks post surgery, 6 months post surgery

• Change from baseline EORTC H&N35 (European Organisation for Research and Treatment of Cancer quality of life questionnaire Head and Neck Module) at 6 weeks

  Quality of Life measurement. The head \& neck cancer module incorporates seven multi-item scales that assess pain, swallowing, senses (taste and smell), speech, social eating, social contact and sexuality. There are also eleven single items. For all items and scales, high scores indicate more problems (i.e. there are no function scales in which high scores would mean better functioning).

  1-2 weeks pre surgery, 3-6 weeks post surgery

• Change from post op 6 weeks EORTC H&N35 (European Organisation for Research and Treatment of Cancer quality of life questionnaire Head and Neck Module) at 6 months

  Quality of Life measurement. The head \& neck cancer module incorporates seven multi-item scales that assess pain, swallowing, senses (taste and smell), speech, social eating, social contact and sexuality. There are also eleven single items. For all items and scales, high scores indicate more problems (i.e. there are no function scales in which high scores would mean better functioning).

  3-6 weeks post surgery, 6 months post surgery

Secondary Outcomes (1)

• Assessing sensory loss secondary to incision / flap elevation and adjuvant therapy

  1-2 weeks pre surgery, 3-6 weeks post surgery, 6 months post surgery

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Outpatients of National Cancer Centre and Singapore General Hospital that have Head and Neck Cancer

You may qualify if:

• Patients with histologically proven cancers of the upper aero-digestive tract (oral cavity, oropharynx, nasopharynx or pharynx), skin, thyroid or salivary glands;
• Case has been indicated for surgical treatment and following adjuvant treatment in the multidisciplinary head and neck tumour board
• Age: 21 - 70 years
• ECOG 0 or 1
• Able to give informed consent

You may not qualify if:

• Patients who are not able to undergo primary resection of their HNC(not fit for general anesthesia)
• Patients with distant metastases or incurable recurrent disease
• Patients who are currently pregnant or breastfeeding
• Patients with a history of shoulder surgery or trauma, or any known joint pathology such as rheumatologic disorders, or prior neurological disease affecting the upper and or lower extremity such as stroke;
• Patients who are receiving a free fibular flap as part of their reconstruction
• Patients who are on a permanent tracheostomy e.g. after a total laryngectomy
• Patient with ischaemic heart disease or with current beta blocker medication

Sponsors & Collaborators

• Singapore General Hospital: lead
• National Cancer Centre, Singapore: collaborator

Study Sites (2)

National Cancer Centre

Singapore, Singapore

Location

Singapore General Hospital

Singapore, Singapore

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2021
• First Posted: September 8, 2021
• Study Start: January 23, 2017
• Primary Completion: January 22, 2018
• Study Completion: January 22, 2018
• Last Updated: September 8, 2021

Record last verified: 2021-08

Locations

SG (2)